Secondary Packaging Supervisor

Job Purpose: 

Oversees the production machine operations while assisting with additional duties and responsibilities as needed or required, and performs other tasks as assigned or apparent.

Essential Duties and Responsibilities:

• Communication to/from peers via production log book, and face-to-face communication with on coming/off-going supervisor.

• Ensure product lines are running within time guidelines for changeovers, with correct lot# and expiration date, formulations, clean in place and product transfer.

• Verify all Batch Records and Lot Records are complete to meet GMP requirements to include all required signatures and or initials.

• Ensure training of new hires and any personnel involved in cross training.

• Monitor employee attendance/tardiness and provide guidance and discipline when appropriate, monitor timecards, vacations, personal time, etc., to ensure production lines are staffed in order to meet the production requirements.

• Perform administrative duties to include personnel roster, personnel scheduling, and monitoring production line.

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Supplemental Functions: 

• Assists with monitoring all production areas and personnel for adherence to all cGMP, SOPs, and safety regulations.

• Assist with development of solutions for chronic problems within quality assurance

• Communicate quality- related observations, issues, problems, discrepancies and any violations of company policies or procedures to Quality Management.

• Adherence to cGMPs is required at all times. All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.

• Stay abreast of current FDA requirements and ensure compliance by familiarity with important department Standard Operating Procedures (SOPs) and routine observance of procedures being performed.

• Assist in other activities (as needed) for Quality Assurance management.